Back to resultsComputerized Anxiety Treatment for Suicide (CATS)
Primary Purpose
Anxiety, Suicide
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Anxiety Sensitivity Treatment
Physical Health Education Training
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring computerized intervention, cognitive bias modification, anxiety, suicide
Eligibility Criteria
Inclusion Criteria:
- Meet diagnostic criteria for a primary Axis 1 anxiety disorder or meet diagnostic criteria for a unipolar mood disorder along with an Axis 1 anxiety disorder.
- Show evidence of current suicidal ideation (BSS above 6.
- Show elevated AS indicated by scoring at or above the community sample mean on the ASI-Cog (above 9.
Exclusion Criteria:
- No significant medical illness (e.g. sig cardiovascular disease, epilepsy, stroke).
- Current or past psychotic-spectrum disorders or uncontrolled bipolar disorder
- No current substance dependence
- Must be an English speaker.
- Must be 18 years or older.
- Must have normal or corrected vision
- Cannot begin treatment/therapy within 1 month of baseline.
- Cannot begin a new medication within 3 months of baseline.
Sites / Locations
- Anxiety and Behavioral Health Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
The anxiety risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for anxiety sensitivity (AS). The psychoeducational component will focus on the nature of stress and its effect on the body. Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced.
The control condition will be a combination of information about general health and wellness (e.g. diet, exercise etc.) plus an inert Cognitive Bias Modification (CBM-I) task.
Outcomes
Primary Outcome Measures
Anxiety Sensitivity Index-3 (ASI-3)
The ASI-3 is an 18-item self-report measure of anxiety sensitivity (AS). This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides. Each subfactor is represented by six items. The measure has shown good psychometric properties.
Secondary Outcome Measures
Beck Suicide Scale (BSS)
The BSS is a 21-item widely used self-report measure assessing a broad spectrum of behaviors and attitudes related to suicide risk, including suicidal ideation and past suicide attempts. It has demonstrated strong reliability and validity.
Full Information
NCT ID
NCT01990131
First Posted
November 15, 2013
Last Updated
August 8, 2016
Sponsor
Florida State University
1. Study Identification
Unique Protocol Identification Number
NCT01990131
Brief Title
Computerized Anxiety Treatment for Suicide
Acronym
CATS
Official Title
Suicide Risk Prevention Among Patients With Anxiety Psychopathology
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.
Detailed Description
CATS is a newly developed computerized treatment targeting specific risk factors associated with anxiety symptoms and suicidal thoughts. Individuals will be asked to complete four appointments, where they will complete various self-report questionnaires as well as a newly developed computerized treatment targeting risk factors associated with anxiety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Suicide
Keywords
computerized intervention, cognitive bias modification, anxiety, suicide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The anxiety risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for anxiety sensitivity (AS). The psychoeducational component will focus on the nature of stress and its effect on the body. Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control condition will be a combination of information about general health and wellness (e.g. diet, exercise etc.) plus an inert Cognitive Bias Modification (CBM-I) task.
Intervention Type
Other
Intervention Name(s)
Cognitive Anxiety Sensitivity Treatment
Other Intervention Name(s)
Computerized Anxiety Treatment for Suicide (CATS)
Intervention Type
Other
Intervention Name(s)
Physical Health Education Training
Primary Outcome Measure Information:
Title
Anxiety Sensitivity Index-3 (ASI-3)
Description
The ASI-3 is an 18-item self-report measure of anxiety sensitivity (AS). This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides. Each subfactor is represented by six items. The measure has shown good psychometric properties.
Time Frame
Month 4 follow-up
Secondary Outcome Measure Information:
Title
Beck Suicide Scale (BSS)
Description
The BSS is a 21-item widely used self-report measure assessing a broad spectrum of behaviors and attitudes related to suicide risk, including suicidal ideation and past suicide attempts. It has demonstrated strong reliability and validity.
Time Frame
Month 4 follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet diagnostic criteria for a primary Axis 1 anxiety disorder or meet diagnostic criteria for a unipolar mood disorder along with an Axis 1 anxiety disorder.
Show evidence of current suicidal ideation (BSS above 6.
Show elevated AS indicated by scoring at or above the community sample mean on the ASI-Cog (above 9.
Exclusion Criteria:
No significant medical illness (e.g. sig cardiovascular disease, epilepsy, stroke).
Current or past psychotic-spectrum disorders or uncontrolled bipolar disorder
No current substance dependence
Must be an English speaker.
Must be 18 years or older.
Must have normal or corrected vision
Cannot begin treatment/therapy within 1 month of baseline.
Cannot begin a new medication within 3 months of baseline.
Facility Information:
Facility Name
Anxiety and Behavioral Health Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32304
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28287798
Citation
Schmidt NB, Norr AM, Allan NP, Raines AM, Capron DW. A randomized clinical trial targeting anxiety sensitivity for patients with suicidal ideation. J Consult Clin Psychol. 2017 Jun;85(6):596-610. doi: 10.1037/ccp0000195. Epub 2017 Mar 13.
Results Reference
derived
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Computerized Anxiety Treatment for Suicide
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